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Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected adults.

A Double Blind Phase II Study of Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ Lymphocyte Recovery in Subjects on Potent Antiretroviral Therapy With Plasma HIV-1 RNA Levels of 200 Copies Per Milliliter or Less

Median and inter-quartile range of the change in absolute CD4 count from baseline to study week 12 were calculated for each treatment arm. Baseline CD4+ count was defined as the average of pre-entry and entry CD4 count. If one evaluation was missing, the other one was used. If a subject missed a week 12 CD4 count evaluation, then the CD4 count evaluation obtained after starting study treatment and closest in time to week 12 (using the earlier evaluation if necessary to break a tie) was used in place of the missing week 12 evaluation.

Secondary Outcome Measures:

Qualitative Hepatitis C Virus RNA [ Time Frame: At study entry ]

Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24 [ Time Frame: From randomization to week 24 ]

Number of subjects had a grade 3 or 4 toxicity for signs and symptoms. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.

Participants will receive palifermin placebo injection on Days 1, 2, and 3

Drug: Palifermin placebo

Keratinocyte growth factor placebo administered via injection

Other Name: rHuKGF placebo

Experimental: 2

Participants will receive palifermin 20 mcg/kg injection on Days 1, 2, and 3

Drug: Palifermin

Keratinocyte growth factor administered via injection

Other Name: rHuKGF

Experimental: 3

Participants will receive palifermin 40 mcg/kg injection on Days 1, 2, and 3

Drug: Palifermin

Keratinocyte growth factor administered via injection

Other Name: rHuKGF

Experimental: 4

Participants will receive palifermin 60 mcg/kg injection on Days 1, 2, and 3

Drug: Palifermin

Keratinocyte growth factor administered via injection

Other Name: rHuKGF

Detailed Description:

Antiretroviral therapy (ART) has dramatically improved the clinical outcome for HIV infected adults; however, some people on potent ART experience poor recovery of CD4 counts despite maximum suppression of viral load. Such uncontrolled HIV infection is associated with the reduced ability by the human body to create new T cells (or thymopoiesis). HIV infected adults experiencing reduced thymopoiesis are at increased risk of clinical disease progression.

The thymus is the primary site for CD4 cell development; research suggests that keratinocyte growth factor (KGF) may enhance thymus activity in individuals who exhibit reduced thymopoiesis. Palifermin is a modified version of the naturally occurring KGF that is approved to treat people with hematologic malignancies. The purpose of this study is to evaluate the safety and efficacy of palifermin in increasing CD4 counts, through enhanced thymopoiesis, in treatment-experienced HIV infected adults with suppressed viral loads but low CD4 counts.

This study will last 24 weeks. Participants will be randomly assigned to one of four arms:

Arm A participants will receive placebo

Arm B participants will receive palifermin 20 mcg/kg

Arm C participants will receive palifermin 40 mcg/kg

Arm D participants will receive palifermin 60 mcg/kg

Participants will receive intravenous doses of their assigned intervention on Days 1, 2, and 3. All participants must remain on their current ART regimen for the duration of the study. ART will not be provided by the study. There will be six study visits, and they will occur at Weeks 1, 2, 4, 8, 12, and 24. All visits will include a targeted physical exam and blood and urine collection.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV infected

Receiving potent ART, defined as a combination of three or more antiretroviral drugs for at least 6 months prior to study entry

CD4 count of 200 cells/mm3 or less within 30 days prior to study entry

Documented CD4 count obtained at study screening

Documented current, persistent viral load less than or equal to 200 copies/ml for at least 6 months prior to study entry

Willing to use acceptable forms of contraception for the duration of the study

Systemic cancer chemotherapy within 30 days prior to study entry, or history of radiation therapy to the neck and chest regions at any time.

Allergy or sensitivity to any component of palifermin

Prior treatment with palifermin or other keratinocyte growth factors

Current drug or alcohol use that, in the opinion of the investigator, may interfere with study participation

Serious illness or recent surgery that requires systemic treatment or hospitalization. Participants who have completed therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded.

Active cancer

HIV-1 RNA levels >200 copies/mL within 6 months prior to study entry

Pregnant or breastfeeding

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376935

Locations

United States, California

USC CRS

Los Angeles, California, United States, 90033

UCLA CARE Center CRS

Los Angeles, California, United States, 90035

Stanford CRS

Palo Alto, California, United States, 94304

Ucsd, Avrc Crs

San Diego, California, United States, 92103

Harbor-UCLA Med. Ctr. CRS

Torrance, California, United States, 90502

United States, Florida

Univ. of Miami AIDS CRS

Miami, Florida, United States, 33136-1013

United States, Georgia

The Ponce de Leon Ctr. CRS

Atlanta, Georgia, United States, 30308

United States, Maryland

IHV Baltimore Treatment CRS

Baltimore, Maryland, United States, 21201

United States, Massachusetts

Bmc Actg Crs

Boston, Massachusetts, United States, 02118

United States, Missouri

Washington U CRS

St. Louis, Missouri, United States, 63108-2138

United States, New York

NY Univ. HIV/AIDS CRS

New York, New York, United States, 10016

Columbia P&S CRS

New York, New York, United States, 10032-3732

Trillium Health ACTG CRS

Rochester, New York, United States, 14607

Univ. of Rochester ACTG CRS

Rochester, New York, United States, 14642

United States, North Carolina

Unc Aids Crs

Chapel Hill, North Carolina, United States, 27514

Duke Univ. Med. Ctr. Adult CRS

Durham, North Carolina, United States, 27710

United States, Ohio

Case CRS

Cleveland, Ohio, United States, 44106

MetroHealth CRS

Cleveland, Ohio, United States, 44109

The Ohio State University Medical Center

Columbus, Ohio, United States, 43210

United States, Pennsylvania

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, United States, 19104

United States, Tennessee

Vanderbilt Therapeutics CRS

Nashville, Tennessee, United States, 37204

United States, Washington

University of Washington AIDS CRS

Seattle, Washington, United States, 98104

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

AIDS Clinical Trials Group

Investigators

Study Chair:

Jeffrey M. Jacobson, MD

Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine